AbbVie Inc. — Vraylar FDA Review (NDA204370, SUPPL 9, 2022)
AbbVie Inc. · 2022 · FDA Review (openFDA) · company profile →
Report summary
On December 16, 2022, AbbVie Inc. received FDA approval for a supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine) capsules, expanding its indication to include adjunctive therapy for Major Depressive Disorder (MDD) in adults. VRAYLAR is also approved for schizophrenia and bipolar I disorder. The approval was supported by multiple clinical trials (RGH-MD-75, 3111-301-001, 3111-302-001), with two out of three primary efficacy studies demonstrating significant improvement in MADRS total scores for MDD. Efficacy was also established for bipolar mania and depression. Safety data, consistent with VRAYLAR's existing indications, highlighted common adverse events such as akathisia, weight gain, and other extrapyramidal symptoms (EPS). While overall serious adverse event rates were similar to placebo, psychiatric and nervous system-related events, particularly akathisia and anxiety, were dose-dependent. The maximum recommended daily dose is 6 mg due to dose-related adverse reactions. Regulatory reviews, including ophthalmology and statistical analyses, found no significant issues impeding approval.
Key findings — cited to the page
| Adverse event | fatigue | Study RGH-MD-75 · p.256 |
| Supplemental New Drug Application Approval | new indication of adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults | Vraylar (cariprazine) capsules · p.4 |
| Approval Date | December 16, 2022 | · p.7 |
| Boxed Warning | Increased Mortality in Elderly Patients with Dementia-Related Psychosis | VRAYLAR · p.9 |
| Boxed Warning | Suicidal Thoughts and Behaviors | VRAYLAR · p.9 |
| Indication | Treatment of schizophrenia in adults | VRAYLAR · p.9 |
| Indication | Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults | VRAYLAR · p.9 |
| Indication | Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults | VRAYLAR · p.9 |
| Indication | Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults | VRAYLAR · p.9 |
| Recommended Starting Dose | 1.5 mg daily | VRAYLAR · p.9 |
| Recommended Dose Range | 1.5 mg to 6 mg daily | VRAYLAR · p.9 |
| Adverse event | akathisia | Study RGH-MD-75 · p.256 |
Source: AbbVie Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →